Spectranetics Bridge Catheter Recall: Possible Guidewire Delay Risk
Spectranetics recalls specific Bridge Occlusion Balloon catheters due to potential guidewire passage issues, risking treatment delays in emergency procedures.
Use caution until it’s fixed
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Contact the company
What happened, in plain English
Spectranetics is recalling certain Bridge Occlusion Balloon catheters that may cause delays in passing a guidewire during emergency procedures. This could lead to treatment delays for patients with superior vena cava tears. Read more at govinfonow.com/recall/73168-spectranetics-bridge-catheter-recall-possible-guidewire-delay-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73168-spectranetics-bridge-catheter-recall-possible-guidewire-delay-risk · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3106-2017
Cite this page
“Spectranetics Bridge Catheter Recall: Possible Guidewire Delay Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73168-spectranetics-bridge-catheter-recall-possible-guidewire-delay-risk. Based on FDA recall #Z-3106-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3106-2017%22&limit=1).
Why it’s dangerous
The catheter may not allow the guidewire to pass through properly, which could delay critical treatment for patients with superior vena cava tears. This delay might impact emergency procedures like lead extraction surgeries.
Who’s affected
Healthcare professionals using these catheters for emergency procedures involving superior vena cava tears. Patients receiving treatment with these devices are at risk of delayed care.
How to tell if you have this one
Check for model number 590-001 with lots FMN17B13A through FMN17J28A. These catheters are used in emergency procedures for superior vena cava tears and are sold only to medical professionals.
- Brand
Spectranetics- Category
Medical device
What to do — step by step
Check Device Lot Number
Identify the lot number on the catheter packaging to determine if it's in the affected range (FMN17B13A through FMN17J28A).
Contact Manufacturer
Reach out to Spectranetics Corporation for guidance on next steps if the device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3106-2017 (August 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3106-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.