Z-0012-2024Class II

Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

Name: Z-0012-2024 Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Creator: Boston Scientific Corporation
Published: 2023-07-27
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2023-07-27 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter on 2023-07-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0012-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-27
Posted: 2023-10-03
Recalling firm: Boston Scientific Corporation
Product: Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Stryker issued an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice to it consignees on 07/31/2023. The notice explained the issue, potential risk, and required the following actions be taken: 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. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately.
Quantity in commerce: 2245 units
Distribution: US Nationwide distribution in the state of Indiana.
Product codes and lots: GTIN 08714729202509, Lot/Batch Numbers: 26059397, 26338716, 25822912, 25822914, 25822915, 25822916, 26059642, 26584704, 26585219, 26745658, 26745659, 26891768, 27177893, 27412261, 27504202, 27568860, 27754498, 27816607, 28100259, 28384661, 28502671, 28737894, 28737895, 26745657, 27177892, 28320873, 28584618, 28795038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0012-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0009-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0010-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0011-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0012-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0013-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0014-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0015-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0016-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0017-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0018-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0019-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0020-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0021-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0022-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0023-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03
Z-0024-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03

Product code DQY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)