Z-0181-2021Class II

Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July...

Name: Z-0181-2021 Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July...
Creator: Boston Scientific Corporation
Published: 2020-08-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-08-24 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI... on 2020-08-24. FDA classified it as Class II and gives the reason as "Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0181-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-24
Posted: 2020-10-22
Terminated: 2024-04-05
Recalling firm: Boston Scientific Corporation
Product: Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Product code: OBJ Catheter, Ultrasound, Intravascular
Reason for recall: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All affected customers were sent a letter on 08/24/2020 stating the following: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.
Quantity in commerce: 41 devices
Distribution: US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA.
Product codes and lots: Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0181-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0181-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-22

Product code OBJ

K200733Class IIOpticross 35 15 MHz Peripheral Imaging CatheterBoston Scientific Corporation / cleared 2020-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)