Home › COOK INCORPORATED › Cook
Cook
COOK INCORPORATED · Model G14511 · UDI-DI 00827002145115
GBL
Prescription
0
510(k) clearances
135
Adverse events
2
Recalls
1
Facilities
Description
Open-End Ureteral Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-04 | Cook Inc. | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| 2016-04-15 | Cook Inc. | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a devi |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.