Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported October 12, 2016
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Cardiovascular Systems Corporation recalled CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/… - a low-severity action.
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/… was recalled by Terumo Cardiovascular Systems Corporation in October 12, 2016. Reason: Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying t…. Check the official notice for the remedy. Verify recall #Z-0001-2017 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this low-severity FDA Devices recall-Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying t….
- Low
- severity level
- 140K units
- affected scope
- Class III
- classification
- October 12, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0001-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0001-2017) was formally reported on October 12, 2016, with the manufacturer initiating the action on December 11, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Terumo Cardiovascular Systems Corporation is listed as the recalling firm, operating out of Elkton, MD. Federal records list the affected scope as 140,000 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Distribution.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
140,000 units
Related Recalls
6
3 from same agency
Product description
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0001-2017 |
| Date reported | October 12, 2016 |
| Date initiated | December 11, 2015 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Firm location | Elkton, MD |
| Affected scope | 140,000 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution. |
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-0001-2017) 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? ▼
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 140,000 units.
Why was this product recalled? ▼
Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2016. Severity: Low. Recall number: Z-0001-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0001-2017) 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 October 12, 2016. 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.