Device recall: Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

Class II FDA enforcement event 92785. Recall start date: 27 Jul 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Boston Scientific Corporation started this device recall on 27 Jul 2023. The firm address in the FDA record is in Maple Grove, MN. FDA put the recall in Class II. FDA event 92785 has 16 product records. The first FDA enforcement report date is 11 Oct 2023. The record gives the status Ongoing.

FDA enforcement report The 16 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution in the state of Indiana.

Recalling firm

Boston Scientific Corporation, Maple Grove, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

16 product records in the event.

FDA event 92785: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0009-2024	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter	4990 units	Class II	Ongoing	11 Oct 2023
Z-0010-2024	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter	4426 units	Class II	Ongoing	11 Oct 2023
Z-0011-2024	Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter	8475 units	Class II	Ongoing	11 Oct 2023
Z-0012-2024	Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter	2245 units	Class II	Ongoing	11 Oct 2023
Z-0013-2024	Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter	3783 units	Class II	Ongoing	11 Oct 2023
Z-0014-2024	Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter	17436 units	Class II	Ongoing	11 Oct 2023
Z-0015-2024	Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter	1086 units	Class II	Ongoing	11 Oct 2023
Z-0016-2024	Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter	326 units	Class II	Ongoing	11 Oct 2023
Z-0017-2024	Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter	1728 units	Class II	Ongoing	11 Oct 2023
Z-0018-2024	Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter	1004 units	Class II	Ongoing	11 Oct 2023
Z-0019-2024	Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter	2184 units	Class II	Ongoing	11 Oct 2023
Z-0020-2024	Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter	3738 units	Class II	Ongoing	11 Oct 2023
Z-0021-2024	Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter	828 units	Class II	Ongoing	11 Oct 2023
Z-0022-2024	Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter	3777 units	Class II	Ongoing	11 Oct 2023
Z-0023-2024	Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter	1170 units	Class II	Ongoing	11 Oct 2023
Z-0024-2024	Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter	116 units	Class II	Ongoing	11 Oct 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class II: 88%
Product records in this event: 16Median of the firm: 2
Events of the firm on the register: 162

Other events of the firm

Other FDA enforcement events of Boston Scientific Corporation
Initiated	Product (first record)	Type	Class	Records
6 Aug 2026	LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Ver	Device	Class II	3
22 Jul 2026	Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1)	Device	Class II	1
14 Jul 2026	OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.	Device	Class II	2
9 Jul 2026	Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter	Device	Class I	2
30 Jun 2026	Rapid Refill Continuous Injection System, UPN M00566001	Device	Class II	1
30 Jun 2026	Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20;	Device	Class II	3
19 Jun 2026	Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing Sys	Device	Class II	1
11 Jun 2026	FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, M	Device	Class II	4
11 Jun 2026	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet	Device	Class II	3
11 Jun 2026	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet	Device	Class II	1

Boston Scientific Corporation: all 162 events

Official channels

FDA enforcement report Z-0009-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 92785. https://recallregister.com/fda/ii/92785/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide distribution in the state of Indiana.
What quantity of product is in FDA event 92785?: The event has 16 product records. The first record gives this quantity: 4990 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 are in Class II.