The Recall Desk

FDA (Devices) recall action 79424

Boston Scientific Corporation recalled 6 products on 2018-03-28

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2018-03-28
Critical
0
Units
12,218

Why these products were recalled

Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.

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.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2018-03-28

    Boston Scientific Recalls Re-Entry Malecot Nephrostomy Catheter Sets

    Boston Scientific is recalling specific Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "
    Category
    Distribution
    43 states
  • SevereFDA (Devices)··2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/p
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "
    Category
    Distribution
    43 states
  • SevereFDA (Devices)··2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling certain Malecot Nephrostomy Catheters because they are breaking at the mid-shaft bond during use.

    Product
    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling 422 units of Malecot Nephrostomy Catheters because they may break at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy C
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they are breaking at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/p
    Category
    Distribution
    43 states