Boston Scientific Corporation: Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Inte

Hazard

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

Details from the source

Reason for recall: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter. Distribution: Worldwide distribution. Quantity: 39739 units Lot/code info: 1. H74904526011, GTIN 8714729177029, Lot Numbers: 34915076, 35065978; 2. H74904526052, GTIN 8714729127062, Lot Numbers: 34915078, 34915220; 3. M0067101140, GTIN 8714729755814, Lot Numbers: 34892421; 4. M001151050, GTIN 8714729183624, Lot Numbers: 34966934; 5. M001151062, GTIN 8714729137542, Lot Numbers: 34873498; 6. M00566670, GTIN 8714729755241, Lot Numbers: 35045668.

UPC codes

8714729177029, 8714729127062, 8714729755814, 8714729183624, 8714729137542, 8714729755241

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.