Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-1302-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

Product Classification:

Class I

Date Initiated: February 12, 2024

Date Posted: April 3, 2024

Recall Number: Z-1302-2024

Event ID: 94082

Reason for Recall:

Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).

Status: Ongoing

Product Quantity: 461 devices

Code Information:

GTIN 08714729992684, Batch Numbers: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976

Distribution Pattern:

Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan

Voluntary or Mandated:

Voluntary: Firm initiated