Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 18, 2017
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation catheter and equipment out of immedi
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Stryker Sustainability Solutions recalled Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation cathe… - a moderate-severity action.
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation cathe… was recalled by Stryker Sustainability Solutions in January 18, 2017. Reason: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.. Check the official notice for the remedy. Verify recall #Z-0963-2017 with the FDA Devices before acting.
The recall
Stryker Sustainability Solutions issued this moderate-severity FDA Devices recall-A breach in the sterile packaging may have occurred resulting in potentially non-sterile product..
- Moderate
- severity level
- Class II
- classification
- January 18, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0963-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0963-2017) was formally reported on January 18, 2017, with the manufacturer initiating the action on December 6, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Sustainability Solutions is listed as the recalling firm, operating out of Tempe, AZ. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. Distribution data in the federal record shows the product reached: U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT Foreign distribution to the following: CA.. 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
Unknown
Related Recalls
6
3 from same agency
Product description
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation catheter and equipment out of immediate reach.
Reason for recall
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0963-2017 |
| Date reported | January 18, 2017 |
| Date initiated | December 6, 2016 |
| Recalling firm | Stryker Sustainability Solutions |
| Firm location | Tempe, AZ |
| Affected scope | Not disclosed |
| Distribution | U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT Foreign distribution to the following: CA. |
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-0963-2017) 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? ▼
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation catheter and equipment out of immediate reach.. Recalled by Stryker Sustainability Solutions.
Why was this product recalled? ▼
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0963-2017.
Where was the recalled product distributed? ▼
Distribution: U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT Foreign distribution to the following: CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0963-2017) 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 January 18, 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.