Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 23, 2013
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Vycor Medical, Inc. recalled Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Produc… - a critical-severity action.
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Produc… was recalled by Vycor Medical, Inc. in January 23, 2013. Reason: Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber wa…. Check the official notice for the remedy. Verify recall #Z-0673-2013 with the FDA Devices before acting.
The recall
Vycor Medical, Inc. issued this critical-severity FDA Devices recall-Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber wa….
- Critical
- severity level
- 3K units
- affected scope
- Class I
- classification
- January 23, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0673-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0673-2013) was formally reported on January 23, 2013, with the manufacturer initiating the action on August 21, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Vycor Medical, Inc. is listed as the recalling firm, operating out of Boca Raton, FL. Federal records list the affected scope as 3000 devices.
The documented reason for this recall is: Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.. 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, 3 from FDA Devices - 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3000 devices
Related Recalls
6
3 from same agency
Product description
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Reason for recall
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0673-2013 |
| Date reported | January 23, 2013 |
| Date initiated | August 21, 2012 |
| Recalling firm | Vycor Medical, Inc. |
| Firm location | Boca Raton, FL |
| Affected scope | 3000 devices |
| Distribution | Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan. |
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-0673-2013) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.. Recalled by Vycor Medical, Inc.. Units affected: 3000 devices.
Why was this product recalled? ▼
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 23, 2013. Severity: Critical. Recall number: Z-0673-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0673-2013) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 23, 2013. 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.