Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 28, 2020
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.
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 d…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Boston Scientific Corporation recalled Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date Jun… - a moderate-severity action.
Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date Jun… was recalled by Boston Scientific Corporation in October 28, 2020. Reason: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length marking…. Check the official notice for the remedy. Verify recall #Z-0181-2021 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this moderate-severity FDA Devices recall-Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length marking….
- Moderate
- severity level
- 41 units
- affected scope
- Class II
- classification
- October 28, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0181-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0181-2021) was formally reported on October 28, 2020, with the manufacturer initiating the action on August 24, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Boston Scientific Corporation is listed as the recalling firm, operating out of Quincy, MA. Federal records list the affected scope as 41 devices.
The documented reason for this recall is: 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 ha… Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
41 devices
Related Recalls
6
0 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0181-2021 |
| Date reported | October 28, 2020 |
| Date initiated | August 24, 2020 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Quincy, MA |
| Affected scope | 41 devices |
| Distribution | US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0181-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 41 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0181-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0181-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported October 28, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.