Severity
Moderate
FDA Devices recall · Reported March 1, 2017
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
Vascular Solutions, Inc. recalled GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usa… - a moderate-severity action.
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usa… was recalled by Vascular Solutions, Inc. in March 1, 2017. Reason: Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter th…. Check the official notice for the remedy. Verify recall #Z-1250-2017 with the FDA Devices before acting.
The recall
Vascular Solutions, Inc. issued this moderate-severity FDA Devices recall-Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter th….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1250-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1250-2017) was formally reported on March 1, 2017, with the manufacturer initiating the action on January 12, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Vascular Solutions, Inc. is listed as the recalling firm, operating out of Maple Grove, MN. Federal records list the affected scope as 633.
The documented reason for this recall is: Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of NH, ME, VT, NY, LA, MS, AL CA, IA, WA, OR, MD, DE, PA, NJ, ID, TX, OK, MO, WI, GA, FL, AR, OH, AZ.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
633
Related Recalls
6
3 from same agency
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1250-2017 |
| Date reported | March 1, 2017 |
| Date initiated | January 12, 2017 |
| Recalling firm | Vascular Solutions, Inc. |
| Firm location | Maple Grove, MN |
| Affected scope | 633 |
| Distribution | US Nationwide Distribution in the states of NH, ME, VT, NY, LA, MS, AL CA, IA, WA, OR, MD, DE, PA, NJ, ID, TX, OK, MO, WI, GA, FL, AR, OH, AZ. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 1, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.