Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 30, 2016
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initi
Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Greatbatch Medical recalled Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Mic… - a moderate-severity action.
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Mic… was recalled by Greatbatch Medical in November 30, 2016. Reason: Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a fiel…. Check the official notice for the remedy. Verify recall #Z-0623-2017 with the FDA Devices before acting.
The recall
Greatbatch Medical issued this moderate-severity FDA Devices recall-Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a fiel….
- Moderate
- severity level
- 23K units
- affected scope
- Class II
- classification
- November 30, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0623-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0623-2017) was formally reported on November 30, 2016, with the manufacturer initiating the action on September 8, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Greatbatch Medical is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 23,075.
The documented reason for this recall is: Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use. Distribution data in the federal record shows the product reached: US: NY, TX.. 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.
Medical Devices recalls over time
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.
Affected scope
23,075
Related Recalls
6
3 from same agency
Product description
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers in a bulk non-sterile configuration.
Reason for recall
Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0623-2017 |
| Date reported | November 30, 2016 |
| Date initiated | September 8, 2016 |
| Recalling firm | Greatbatch Medical |
| Firm location | Plymouth, MN |
| Affected scope | 23,075 |
| Distribution | US: NY, TX. |
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.
- Check the recall number (Z-0623-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers in a bulk non-sterile configuration.. Recalled by Greatbatch Medical. Units affected: 23,075.
Why was this product recalled? ▼
Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2016. Severity: Moderate. Recall number: Z-0623-2017.
Where was the recalled product distributed? ▼
Distribution: US: NY, TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0623-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 November 30, 2016. 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.