FDA Cites Lion Street Medical, d/b/a Pensar Medical LLC in 2026-08-21 Warning Letter — Medical Device Reporting/Misbranded
Letter issued · posted to fda.gov .
Subject as published: Medical Device Reporting/Misbranded
TL;DR
The FDA's Center for Devices and Radiological Health issued a warning letter to Lion Street Medical, d/b/a Pensar Medical LLC (CEO Jason Allen Bandy, Houston, TX) on August 21, 2026 following an inspection from April 14–28, 2026, citing violations in the Medical Device Reporting (MDR) procedures for its WoundPro, WoundPro+, and MicroDoc negative pressure wound therapy systems. The firm's MDR procedure WI103-01 (Rev. 2, dated 12/12/2023) lacks adequate definitions of reportable events, fails to document decision-making processes for reportability determinations, and omits required record-keeping guidance; additionally, the firm did not report Complaint C-029—an infection at the wound site on May 1, 2024—as a serious injury within 30 days as required by 21 CFR 803.50(a)(1), instead submitting it months later as a malfunction report rather than a serious injury report. The firm's corrective action plan (CAPA-045) remained incomplete as of the firm's June 19, 2026 response.
Argus analysis
# FDA Warning Letter Analysis: Lion Street Medical, d/b/a Pensar Medical LLC
**Company and Findings**
Lion Street Medical, operating as Pensar Medical LLC in Houston, Texas, manufactures three negative pressure wound therapy systems: WoundPro NPWT, WoundPro+ NPWT, and MicroDoc (PocketDoc) Portable NPWT. During an FDA inspection from April 14–28, 2026, the Center for Devices and Radiological Health identified significant compliance gaps in medical device reporting (MDR), corrections and removals, and quality management practices. The devices are intended to promote wound healing through continuous or intermittent negative pressure drainage.
**Regulatory Citations and Implications**
The warning cites violations under 21 CFR 803.17 (MDR procedures), 21 CFR 803.50 and 803.52 (serious injury and death reporting timelines), and 21 CFR 806.10 (corrections and removals reporting). These sections require manufacturers to establish written systems for identifying and reporting adverse events within 30 days of awareness, and to notify FDA of device corrections within 10 working days. The company's MDR procedure lacked clear definitions of "reasonably suggests"—a critical term in determining reportability—and failed to document decision-making rationale. One complaint involving wound infection meeting serious injury criteria was submitted as a malfunction rather than serious injury, remaining unreported for over two years. A software correction affecting multiple MicroDoc devices was not reported to FDA.
**Response Timeline and Industry Observations**
Lion Street Medical provided responses on May 19, June 19, and July 20, 2026, but the FDA deemed them inadequate. Draft revised procedures were not expected for implementation until August 31, 2026. Compliance officers in wound care and NPWT sectors should monitor whether the company submits corrected MDRs, implements the revised procedures by deadline, and files the outstanding corrections and removals report. Additional FDA enforcement action is possible if corrective measures prove insufficient or if further unreported events emerge during ongoing monitoring.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
Medical device Warning Letters typically combine QSR observations (21 CFR Part 820) with adulteration (21 USC 351) or misbranding (21 USC 352). Post-market surveillance and MDR reporting (21 CFR Part 803) are recurring subjects.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Lion Street Medical, d/b/a Pensar Medical LLC MARCS-CMS 733015 — August 21, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Jason Allen Bandy Recipient Title Chief Executive Officer (CEO) Lion Street Medical, d/b/a Pensar Medical LLC 109 N Post Oak Ln, Suite 525 Houston , TX 77024-7862 United States (b)(6), (b)(7)(C) Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS #733015 August 21, 2026 Dear Mr. Bandy: During an inspection of your firm located in Houston, TX from April 14, 2026, through April 28, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm, Lion Street Medical, d/b/a Pensar Medical LLC, manufactures the WoundPro Negative Pressure Wound Therapy (NPWT) System, the WoundPro+ NPWT System, and the MicroDoc (PocketDoc) Portable NPWT System (negative pressure wound therapy systems). These products are intended to promote wound healing by draining and removing infectious material and other fluids from the wound site through continuous and/or intermittent negative pressure. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Medical Device Reporting (MDR) Violations Our inspection revealed that your firm’s negative pressure wound therapy systems are misbranded under 21 CFR 803.17 in that your firm failed or refused to develop, maintain, and implement written MDR procedures required by or under section 519 of the Act, 21 U.S.C. § 360i. Significant violations include, but are not limited to, the following: 1. During the inspection, your firm presented its MDR procedure titled “Medical Device Reporting”, WI103-01, Rev. 2, dated 12/12/2023. Upon review, we noted the following deficiencies: a) The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the procedure does not include adequate definitions of what constitutes a reportable event under 21 CFR Part 803. Specifically, the procedure does not include a definition of what “reasonably suggests” whether a reportable event has occurred as it is described in 21 CFR 803.20(c)(1); this may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a). b) The procedure does not describe how your firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b). The procedure also does not include documentation of the deliberations and decision-making processes used to…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- Has Lion Street Medical, d/b/a Pensar Medical LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Lion Street Medical, d/b/a Pensar Medical LLC as of 2026-09-22. Argus ingests new FDA enforcement records daily.
- What FDA violations was Lion Street Medical, d/b/a Pensar Medical LLC cited for?
- The FDA Warning Letter to Lion Street Medical, d/b/a Pensar Medical LLC (issuing office: Center for Devices and Radiological Health) cites: Medical Device Reporting/Misbranded. Classification: Medical device.
- When did FDA issue the warning letter to Lion Street Medical, d/b/a Pensar Medical LLC?
- FDA issued the letter (MARCS-CMS 733015) on 2026-08-21 and posted it publicly on fda.gov on 2026-09-22.
- Is the FDA warning letter to Lion Street Medical, d/b/a Pensar Medical LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lion-street-medical-dba-pensar-medical-llc-733015-08212026.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Cites Lion Street Medical, d/b/a Pensar Medical LLC in 2026-08-21 Warning Letter — Medical Device Reporting/Misbranded. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-lion-street-medical-d-b-a-pensar-medical-llc-2026-08-21-medical-device
"FDA Cites Lion Street Medical, d/b/a Pensar Medical LLC in 2026-08-21 Warning Letter — Medical Device Reporting/Misbranded." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-lion-street-medical-d-b-a-pensar-medical-llc-2026-08-21-medical-device.
Argus HQ Research. "FDA Cites Lion Street Medical, d/b/a Pensar Medical LLC in 2026-08-21 Warning Letter — Medical Device Reporting/Misbranded." Digital Empire Holdings LLC. Accessed September 25, 2026. https://argushq.ai/fda/warning-letter/fda-wl-lion-street-medical-d-b-a-pensar-medical-llc-2026-08-21-medical-device.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_lion_street_medical_d_b_a_pensar_medical_llc_2026_08_21_medical_device_2026,
title = {FDA Cites Lion Street Medical, d/b/a Pensar Medical LLC in 2026-08-21 Warning Letter — Medical Device Reporting/Misbranded},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-lion-street-medical-d-b-a-pensar-medical-llc-2026-08-21-medical-device},
note = {Accessed: September 25, 2026}
}