Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported July 2, 2014
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interve
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nitinol Devices and Components, Inc. recalled HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Ni… - a critical-severity action.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Ni… was recalled by Nitinol Devices and Components, Inc. in July 2, 2014. Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.. Check the official notice for the remedy. Verify recall #Z-1816-2014 with the FDA Devices before acting.
The recall
Nitinol Devices and Components, Inc. issued this critical-severity FDA Devices recall-Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire..
- Critical
- severity level
- Class I
- classification
- July 2, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1816-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1816-2014) was formally reported on July 2, 2014, with the manufacturer initiating the action on May 28, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Nitinol Devices and Components, Inc. is listed as the recalling firm, operating out of Fremont, CA. Federal records list the affected scope as 8485 in US, 9595 - ROW - total, all models.
The documented reason for this recall is: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.. 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
8485 in US, 9595 - ROW - total, all models
Related Recalls
6
3 from same agency
Product description
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
Reason for recall
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1816-2014 |
| Date reported | July 2, 2014 |
| Date initiated | May 28, 2014 |
| Recalling firm | Nitinol Devices and Components, Inc. |
| Firm location | Fremont, CA |
| Affected scope | 8485 in US, 9595 - ROW - total, all models |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada. |
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-1816-2014) 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? ▼
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.. Recalled by Nitinol Devices and Components, Inc.. Units affected: 8485 in US, 9595 - ROW - total, all models.
Why was this product recalled? ▼
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2014. Severity: Critical. Recall number: Z-1816-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1816-2014) 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.
Nearby Recalls in This Category
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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 July 2, 2014. 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.