Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 20, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up t
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Datascope Corporation recalled Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 70105… - a moderate-severity action.
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 70105… was recalled by Datascope Corporation in June 20, 2018. Reason: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.. Check the official notice for the remedy. Verify recall #Z-2180-2018 with the FDA Devices before acting.
The recall
Datascope Corporation issued this moderate-severity FDA Devices recall-There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through..
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- June 20, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2180-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2180-2018) was formally reported on June 20, 2018, with the manufacturer initiating the action on July 27, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Datascope Corporation is listed as the recalling firm, operating out of Fairfield, NJ. Federal records list the affected scope as 8.
The documented reason for this recall is: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. Distribution data in the federal record shows the product reached: The products were distributed to the following US states: IA and FL.. 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 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
8
Related Recalls
6
3 from same agency
Product description
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Reason for recall
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2180-2018 |
| Date reported | June 20, 2018 |
| Date initiated | July 27, 2017 |
| Recalling firm | Datascope Corporation |
| Firm location | Fairfield, NJ |
| Affected scope | 8 |
| Distribution | The products were distributed to the following US states: IA and FL. |
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-2180-2018) 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? ▼
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.. Recalled by Datascope Corporation. Units affected: 8.
Why was this product recalled? ▼
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2180-2018.
Where was the recalled product distributed? ▼
Distribution: The products were distributed to the following US states: IA and FL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2180-2018) 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 June 20, 2018. 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.