Drug recall
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
FDA recall event 92785 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 92785 |
|---|---|
| Recall numbers | Z-0009-2024, Z-0010-2024, Z-0011-2024, Z-0012-2024, Z-0013-2024, Z-0014-2024, Z-0015-2024, Z-0016-2024, Z-0017-2024, Z-0018-2024, Z-0019-2024, Z-0020-2024 and 4 more |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter, Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter, Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter, Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter, Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter and 11 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape… |
| Initiation date | Jul 27, 2023 |
| Report date | Oct 11, 2023 |
| City | Maple Grove |
| State | MN |
| Country | United States |
| FEI number | 3002095335 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: