The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0577-2020·Announced 2019-12-04

Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect

Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Boston Scientific Corporation is recalling specific lots of Emerge Monorail PTCA Dilatation Catheters. These medical devices are used for dilation and extension procedures and are sterilized using ethylene oxide. The recall involves 14,145 devices in various sizes, including 2.00mm, 2.50mm, 3.00mm, 1.50mm, and 3.50mm diameters.

The recall was initiated because the catheters may have missed the hydrophilic coating step during the manufacturing process. This coating is intended to create a lubricious surface on the devices. The affected products were distributed nationwide, including Washington D.C. and Puerto Rico, as well as to Canada.

Healthcare providers and facilities should check their inventory for the specific lot numbers and use-by dates listed in the official recall notice. If the devices are found, they should be removed from service and returned to Boston Scientific Corporation according to the company's instructions.

The recalled product

Product
Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No.…
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiovascular Catheter
Hazard
Affected units
14,145

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 3. Lots: 21311605 / 8714729799894 / 2020-06-23
  • 23960557 / 8714729799894 / 2022-02-11
  • 23975925 / 8714729799894 / 2022-02-13
  • 22402212 / 8714729806103 / 2021-03-15
  • 23881291 / 8714729799917 / 2022-01-25
  • 24088571 / 8714729799917 / 2022-03-07
  • 22532219 / 8714729806127 / 2021-04-16
  • 22760617 / 8714729806127 / 2021-02-05
  • 23021557 / 8714729806127 / 2021-01-11
  • 23181062 / 8714729806127 / 2021-09-10
  • 21309387 / 8714729800002 / 2020-06-23
  • 21363021 / 8714729800002 / 2020-07-06
  • 22734757 / 8714729800026 / 2021-05-29
  • 23047327 / 8714729800026 / 2021-08-03
  • 23946181 / 8714729800026 / 222-02-07
  • 20669615 / 8714729800132 / 2020-01-15

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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