510(k) · Cleared
Recalled · Class II · 2017Percutaneous Draining Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Tech, Inc. · GBW Catheter, Peritoneal
Cleared on Jun 2, 1981 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 6 times.
- Decided
- Jun 2, 1981
- Review
- 18 days
- Class
- Class I
- Product code
- GBW
- Recalls
- 6
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2017 | Class II | Z-1099-2018 | Under Investigation by firm | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| Mar 18, 2009 | Not classified | Z-1336-2009 | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and… |
| Mar 18, 2009 | Not classified | Z-1338-2009 | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and… |
| Mar 18, 2009 | Not classified | Z-1335-2009 | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and… |
| Mar 18, 2009 | Not classified | Z-1334-2009 | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and… |
| Aug 10, 2006 | Not classified | Z-1499-06 | Other | Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GBW devicesGBW Catheter, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBW
FDA has decided no GBW device since 2007.
Median 510(k) review, days · GBW
Too few GBW 510(k)s in any year since 2007 to give a median.
Recalls per year · GBW
6in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBW
28in 2023
MAUDE reports naming product code GBW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 6 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 (1) | — |
https://510kreport.com/device/K811378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811378: Percutaneous Draining Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811378
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026