Cook Incorporated recalls Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters f…
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experienceUDIUDI-DI 00827002119161400 affected lots1690539016905390X16888263NS168882641690539116905391X1690957716918137
+392 more
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What the firm is doing
On April 2, 2026, the firm began notifying affected consignees via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to quarantine affected products in inventory and to immediately cease further distribution and use of the affected products. They should return the affected products to Cook Medical with a copy of the completed Acknowledgement and Receipt form to receive a product credit.
DistributionShow detailsHide
US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1934-2026
- FDA device classification · DQOOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cook IncorporatedSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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