The Recall Desk

FDA (Devices) recall action 72045

Boston Scientific Corporation recalled 2 products on 2015-09-23

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2015-09-23
Critical
0
Units
58,338

Why these products were recalled

Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.

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.

1–2 of 2

  • ModerateFDA (Devices)··2015-09-23

    Boston Scientific WATCHMAN Device Field Correction for Hemostasis Valve Cross-Thread Risk

    Boston Scientific is issuing a field correction for WATCHMAN Left Atrial Appendage Closure Devices to prevent hemostasis valve cross-threading and potential blood leakage.

    Product
    Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-09-23

    Boston Scientific Recalls WATCHMAN Access Sheath Due to Valve Cross-Thread Risk

    Boston Scientific is recalling WATCHMAN Access System sheaths because the hemostasis valve may cross-thread if tightened with the dilator in place, potentially preventing the valve from sealing.

    Product
    Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
    Category
    Distribution
    0 states