The Recall Desk

FDA (Devices) recall action 61935

Boston Scientific Corporation recalled 3 products on 2012-06-27

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2012-06-27
Critical
0
Units
6,070

Why these products were recalled

Difficulty in extending snare loop from the catheter

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling Profile Single-Use Pediatric Snares due to difficulty extending the snare loop from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a thre
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-06-27

    Boston Scientific Recalls Pediatric Polypectomy Snares Due to Extension Difficulty

    Boston Scientific is recalling 1,340 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling 1,970 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three
    Category
    Distribution
    0 states