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High RiskFDAfda-Z-1734-2020OTHER

Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110

Units Affected
32
Recall Date
March 9, 2020
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1734-2020.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1734-2020.

Recall ongoing. Follow firm instructions.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Boston Scientific or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1734-2020.

Boston Scientific

FDA

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📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

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Boston Scientific Recall FAQ

Boston Scientific is the subject of a medical implants safety report: Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110. The notice was published on March 9, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 32 units are potentially affected.