CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report
Guider Softip Guide Catheter 8F Pre-shaped recalled by Boston Scientific
Boston Scientific is recalling Guider Softip Guide Catheter 8F Pre-shaped 40, distributed nationwide in the US. The recall was initiated on 27 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0019-2024
- FDA event ID
- 92785
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jul 2023
- FDA classified
- 3 Oct 2023
- Reported
- 11 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 27 Jul 2023 | Recall initiated by company | |
| 3 Oct 2023 | Classified by FDA | +68 days |
| 11 Oct 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 which differs from the labeled tip curve shape.
Product as listed by the FDA
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Where it was distributed
US Nationwide distribution in the state of Indiana.
Questions about this recall
Is Guider Softip Guide Catheter 8F Pre-shaped 40 recalled?
Yes. Boston Scientific recalled Guider Softip Guide Catheter 8F Pre-shaped 40 on 27 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-0019-2024.
Why was it recalled?
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 which differs from the labeled tip curve shape.
Which lots are affected?
GTIN 08714729244318, Lot/Batch Numbers: 25823581, 26059696, 26130255, 26277192, 26746112, 26984240, 27241920, 25823580, 25964485, 25964486, 25964487, 26059694, 26130254, 26277190, 26277191, 26599708, 26599709, 26599710, 26599711, 26599712, 26746113, 26984241, 26984253, 27203538, 27203539, 27379022, 28384669, 28632346, 28632344
Where was it sold?
US Nationwide distribution in the state of Indiana.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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