CLASS II ONGOING Device recall · Reported 29 Apr 2020 · FDA Enforcement Report
Stretch VL Ureteral Stent Set 6FX22- with .035 Sensor UPN recalled
Boston Scientific is recalling Stretch VL Ureteral Stent Set 6FX22- with .035 Sensor UPN: M006185156080, distributed nationwide in the US. The recall was initiated on 9 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1738-2020
- FDA event ID
- 85227
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Mar 2020
- FDA classified
- 17 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 9 Mar 2020 | Recall initiated by company | |
| 17 Apr 2020 | Classified by FDA | +39 days |
| 29 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
Where it was distributed
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Questions about this recall
Is Stretch VL Ureteral Stent Set 6FX22- with .035 Sensor UPN: M006185156080 recalled?
Yes. Boston Scientific recalled Stretch VL Ureteral Stent Set 6FX22- with .035 Sensor UPN: M006185156080 on 9 Mar 2020. The recall is Class II and its status is Ongoing. Recall number Z-1738-2020.
Why was it recalled?
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Which lots are affected?
Lot Numbers: 24724232
Where was it sold?
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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