Recall Record: Class I Recall: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters… by Cook Incorporated

Key facts

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 (additional items listed in FDA's full record) -- and the recall number Z-1934-2026. If it matches, stop using or distributing it and contact Cook Incorporated or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Cook Incorporated and the affected product is described in FDA's record as: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 (additional items listed in FDA's full record). FDA's stated reason for the recall is: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.. The recall is tracked under FDA recall number Z-1934-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Cook Incorporated’s FDA history

Argus HQ has recorded 21 total FDA actions tied to Cook Incorporated: 0 warning letters, 21 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?

Cook Incorporated recalled Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 (additional items listed in FDA's full record). FDA's record states the reason for recall as: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a.

How serious is this recall?

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification.

What should someone who has this product do?

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 (additional items listed in FDA's full record)) and recall number Z-1934-2026, then follow.

Has Cook Incorporated had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 21 total FDA actions tied to Cook Incorporated, including 21 recalls and 0 warning letters.

Related enforcement actions