Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported November 16, 2016
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .0…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
SentreHeart Inc recalled FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use … - a critical-severity action.
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use … was recalled by SentreHeart Inc in November 16, 2016. Reason: A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking …. Check the official notice for the remedy. Verify recall #Z-0328-2017 with the FDA Devices before acting.
The recall
SentreHeart Inc issued this critical-severity FDA Devices recall-A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking ….
- Critical
- severity level
- Class I
- classification
- November 16, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0328-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0328-2017) was formally reported on November 16, 2016, with the manufacturer initiating the action on September 29, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. SentreHeart Inc is listed as the recalling firm, operating out of Redwood City, CA. Federal records list the affected scope as 132 worldwide distribution (98) of those units in US.
The documented reason for this recall is: A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packag… Distribution data in the federal record shows the product reached: Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
132 worldwide distribution (98) of those units in US
Related Recalls
6
3 from same agency
Product description
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
Reason for recall
A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0328-2017 |
| Date reported | November 16, 2016 |
| Date initiated | September 29, 2016 |
| Recalling firm | SentreHeart Inc |
| Firm location | Redwood City, CA |
| Affected scope | 132 worldwide distribution (98) of those units in US |
| Distribution | Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany |
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-0328-2017) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.. Recalled by SentreHeart Inc. Units affected: 132 worldwide distribution (98) of those units in US.
Why was this product recalled? ▼
A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2016. Severity: Critical. Recall number: Z-0328-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0328-2017) 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 16, 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.