Recall Z-1582-2022 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
| Date | Aug 25, 2022 (initiated Aug 9, 2022) |
| Status | Open, Classified |
| Reason | The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter. |
| Root cause | Process control |
| Action | Stryker notified its consignees by issuing an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice on 8/9/2022 by courier. The notice described the problem and the hazard, and requested the consignee take the following actions: "Required Actions 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to Stryker. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. I |
| Quantity | 184 devices (UPDATED) |
| Distribution | International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution. |
| FDA record | Open on fda.gov |